Maxon

Package Leaflet: Information for the Patient

MAXON, 100 mg, Film-Coated Tablets

Sildenafil

Read All of This Leaflet Carefully Before Taking This Medicine.

• You should keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Pack and Other Information

• 1. What MAXON is and what it is used for
• 2. Before you take MAXON
• 3. How to take MAXON
• 4. Possible side effects
• 5. How to store MAXON
• 6. Contents of the pack and other information

1. What MAXON is and what it is used for

MAXON contains the active substance sildenafil, which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. The medicine works by helping to relax the blood vessels in your penis, allowing blood to flow into your penis when you get sexually excited. MAXON will only help you to get an erection if you are sexually stimulated.

MAXON is used to treat adult men with erectile dysfunction, also known as impotence. This is when a man cannot get, or keep a hard, erect penis suitable for sexual activity.

2. Before you take MAXON

When Not to Take MAXON

• If you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6).
• If you are taking nitrates (see section “Other medicines and MAXON”).
• If you are taking medicines called nitric oxide donors such as amyl nitrite (sometimes called “poppers”).
• If you have recently had a stroke, a heart attack or if you have low blood pressure.
• If you have certain rare inherited eye diseases (such as retinitis pigmentosa).
• If you have ever had loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and Precautions

Before taking MAXON, tell your doctor or pharmacist if you have:

• Sickle cell anemia (an abnormality of the red blood cells), leukemia (cancer of the blood cells), multiple myeloma (cancer of the bone marrow).
• Deformity of your penis or Peyronie's disease.
• Heart problems (e.g. angina, heart failure, irregular heartbeats).
• Had a heart attack or stroke in the past 6 months.
• Low blood pressure.
• Had severe vision loss in one eye due to non-arteritic anterior ischemic optic neuropathy (NAION).

MAXON should not be taken with other treatments for erectile dysfunction, unless advised to do so by your doctor.

MAXON should not be taken with treatments for pulmonary arterial hypertension (PAH) that contain sildenafil or other phosphodiesterase type 5 (PDE5) inhibitors.

MAXON is not intended for use by women.

Children and Adolescents

MAXON should not be used in individuals below 18 years of age.

MAXON with Other Medicines

When taking MAXON with other medicines, you should tell your doctor or pharmacist if you are taking:

• Nitrates or nitric oxide donors.
• Riociguat.
• Medicines for HIV (e.g. ritonavir, saquinavir).
• Oral antifungal medicines (e.g. ketoconazole, itraconazole).
• Antibiotics (e.g. erythromycin, clarithromycin).

Taking MAXON with Food and Drink

MAXON can be taken with or without food.

Pregnancy, Breast-feeding and Fertility

MAXON is not for use in women.

Driving and Using Machines

MAXON may cause dizziness and affect vision. Before driving or operating machinery, patients should be aware of how they react to MAXON.

MAXON Contains Lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

MAXON Contains Sodium

This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

3. How to Take MAXON

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is 50 mg.

Do not take more than one dose of MAXON per day.

Take MAXON about one hour before you plan to have sex. Swallow the tablet whole with a glass of water.

If You Take More MAXON Than You Should

You may be more likely to experience side effects (see section 4).

Do not take more than the recommended dose.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop Taking MAXON and Contact a Doctor Immediately

• Allergic reaction - this is rare (may affect up to 1 in 100 people) Symptoms include sudden wheezing, coughing, chest pain, or tightness, swelling of the eyelids, face, lips, or throat.
• Chest pain - this is uncommon (may affect up to 1 in 100 people) If this occurs during or after sex, and if it doesn’t go away with rest:
• sit or lie down until the pain goes away.
• do not use nitrates to treat the chest pain.
• Prolonged and sometimes painful erections - this is rare (may affect up to 1 in 1,000 people) If you have an erection that lasts more than 4 hours, contact a doctor immediately.

Other Side Effects

Very Common (may affect more than 1 in 10 people):

• Headache.

Common (may affect up to 1 in 10 people):

• Flushing.
• Indigestion.
• Nasal congestion.

Uncommon (may affect up to 1 in 100 people):

• Dizziness.
• Diarrhea.
• Abnormal vision (e.g. blurred vision, changes in color vision, sensitivity to light).

5. How to Store MAXON

Do not store above 30°C.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton.

6. Contents of the Pack and Other Information

What MAXON Contains

• The active substance is sildenafil.
• The other ingredients are microcrystalline cellulose, croscarmellose sodium, magnesium stearate, and silica colloidal anhydrous.

What MAXON Looks Like and Contents of the Pack

MAXON 100 mg is a white, film-coated tablet, in the shape of a capsule, with a rounded edge, and with the marking “100” on one side.

MAXON is available in blister packs containing 1 or 4 tablets.

Marketing Authorisation Holder

Adamed Pharma S.A.

Manufacturer

Adamed Pharma S.A.

Date of Last Revision

GRAŻYNA ANNA MARCINIAK